Please click the link below to access a pdf copy of the presentation given by Kris Ebi on April 9:
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A Better Way to Manufacture Therapeutic Proteins: Engineering Cells to Make Them More Productive
The Evolving Field of Cancer Immunotherapy & Immuno-oncology
Augmented Intelligence in Life Sciences and Healthcare: What Your Data Can Show You (While You Decide What To Do)
Augmented Intelligence in Life Sciences and Healthcare: What Your Data Can Show You (While You Decide What To Do)
Gunnar Carlsson
Artificial intelligence is rapidly developing in many domains, including life sciences and health care. The broader notion of augmented intelligence, where machines interact with humans, is of a great deal of importance. Data sets in life sciences and healthcare are large and complex to the point of being beyond human comprehension.
What if you could “see” the shape of this data in its purest topological form, and interrogate it from this vantage point not achievable with conventional analysis methods? What might you find? What new discoveries might you make? And what might you do next?
Tonight’s talk from Gunnar Carlsson, mathematics Professor Emeritus at Stanford University and co-founder of Ayasdi, will feature examples of a methodology called Topological Data Analysis (TDA) applied to life sciences and healthcare data of a variety of types and sources. This approach has been developing rapidly in the last ten years, supports augmented intelligence, and does not require annotated data.
Case studies of data and derived insights for next step decision-making include:
– stratifying asthma and diabetes based on genomic and phenotypic/EMR data
– identifying optimal clinical care paths for knee replacement and bowel surgery based on variations detected in physician protocol and patient outcomes
– the progression of infectious disease
– the relationship of fMRI data with temporal information about tasks and task transitions
Attention will be given to the process used to examine the data, and how to decide what to do next.
Didn’t see your use case covered? Bring your questions. Whether you are an investigator, drug or device developer, clinician, regulatory professional, basic scientist, or other with a life sciences interest, all questions are welcome at our extended Q&A.
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Securing Connected Medical Devices and the FDA
Securing Connected Medical Devices and the FDA
Rajesh Kanungo, CEO/Founder TalaSecure
Rajesh covered why connected medical device security is important now, go over a Security case studies, Secure Development LifeCycle (mainly threat modeling, static code analysis, secure design, best practices, security testing), FDA premarket requirements, and a bit about post-market requirements.
To see this content, please loginEmbracing Change: Your Connected Medical Device Is Never Finished
Title: Embracing Change: Your Connected Medical Device Is Never Finished
Speaker: Aaron Joseph, Principal Consultant, Sunstone Pilot, Inc.
Date: February 5, 2019
Traditional approaches to medical device development focus on tightly controlling a final product design. In the modern healthcare environment of software-intensive, connected medical devices, there is no final design and companies must become adept at frequently updating their products. Only by embracing change can companies address the modern challenges of connecting to complex, evolving software and rapidly changing cybersecurity risks. This presentation will describe how to structure medical device development for rapid design iterations to speed up product development and to ensure devices remain safe and secure after product launch. Learn how to configure design control processes to support efficient software patches to address interoperability, cybersecurity, OS upgrades, and bug fixes. We will discuss techniques medical device companies can leverage to minimize the cost of change during product development and throughout the product life cycle.
To see this content, please loginMachine Intelligence in Health Care: Why Now?
Title: Machine Intelligence in Health Care: Why Now?
Speaker: Khalid Ashraf, CEO Semion
Date: 11/13/2018
Brief Description:
This talk is targeted towards an uninitiated audience. We will discuss what machine intelligence means. We will show a few toy examples to convey the idea and how such systems are developed. Then we will discuss machine intelligence in the context of healthcare. We will provide a few examples of interesting recent research and industry developments. We will particularly focus on medical image analysis and their diagnosis applications. Finally, we will discuss part of our work at Semion and what keeps us excited
about this field in general.
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To see this content, please loginPackaging Design Validation Testing- Sterilization Methods and Design Considerations
Title: Packaging Design Validation Testing- Sterilization Methods and Design Considerations
Speaker: Pal Khangaldy, Packaging Consultant, Nelson Labs
Date: 10/23/2018
Brief Description:
During the presentation, we will look at some packaging definitions/terminologies associated with sterile medical device packaging. We will look at regulations surrounding medical device packaging and package validation and will take an in-depth look at the actual package validation methods and test standards.
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To see this content, please loginManipulating the Immune System to Treat Disease
Title: Manipulating the Immune System to Treat Disease
Speaker: Prof Edgar Engleman, MD, Professor of Pathology and Medicine, Medical Director, Stanford Blood Center
Date: 10/09/2018
Brief Description:
The immune system is a powerful multicellular system that defends the body against many types of infection, but when misdirected or withheld, it can promote diseases, including cancer and neurodegenerative disorders. Although new therapies are not without risk or toxicity, they can provide dramatic benefits, even for those with advanced cancers. In addition to cancer immunotherapies, new types of immunotherapy are being developed to treat neurodegenerative diseases. In the future, combined treatment with immunotherapy and other agents will likely control and possibly cure many diseases that have heretofore been considered untreatable.
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To see this content, please loginRegulatory Intelligence and Strategy Planning using Magellan and SaaS Technology
Title: Regulatory Intelligence and Strategy Planning using Magellan and SaaS Technology
Speaker: Mark Thomson, President and CEO, RegIQ Solutions, Inc.
Date: 09/25/2018
Brief Description:
Interested in improving your regulatory process for medical device? This presentation is on Magellan, the first SAAS regulatory compliance platform for medical devices with onboard market specific intelligence, project planning, and license management capabilities. Magellan is unique, game-changing technology and a great improvement to current regulatory practice for presubmission planning and post-market management.
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